Valves are important structures in the human heart because they maintain blood flow in a single direction with minimal pressure loss. However, human heart valves can degenerate for a variety of reasons. A malfunctioning heart valve may be stenotic, where the leaflets of the valve do not open fully, or it may be regurgitant, where the leaflets of the valve do not close properly, or a combination of both. Valve repair and replacement procedures have thus been developed to either restore the function of the native valves or to implant a permanent prosthetic valve with or without removal of the original native valve. The standard surgical procedure involves the opening of the patient's thoracic cavity, which is highly invasive and requires cardiopulmonary bypass and prolonged recovery time.
Percutaneous valve repair and replacement procedures have been developed as cheaper and safer substitutes for the traditional open chest surgeries. Compared to traditional surgery, a percutaneous procedure is minimally invasive and it eliminates the need for cardiopulmonary bypass. In the absence of cardiopulmonary bypass, the percutaneous procedure must take place quickly to restore normal circulation, because native valve function is interrupted during the repair or the positioning and implantation of the permanent prosthetic valve. A temporary valve is a useful correlate to maintain unidirectional blood flow during the percutaneous procedure and is particularly useful in conjunction with the deployment of modular percutaneous valve devices, which require assembly prior to implantation.
Additionally, the manipulation of the delivery device, repair tools and/or valve device during a percutaneous valve repair or valve replacement procedure may dislodge tissue and/or tissue adherents such as calcium deposits and/or generate thrombi. This debris may form emboli that travel through the circulatory system and block smaller vessels, which can lead to severe complications, such as stroke, tissue ischemia or death. Consequently, it is desirable to have a filtering device to trap the emboli.
Therefore, a need exists for a single device that can simultaneously address both problems in the art, more specifically, a device that can both maintain blood flow in a single direction and contain the movement of emboli during a percutaneous valve repair or replacement procedure is highly desirable.